ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical
company focused on the development and commercialization of
therapeutic drugs for the treatment of hepatitis B virus (HBV)
announced today, the presentation of new data on TXL™ and CRV431 at
the 53rd Annual International Liver Congress™ 2018 (EASL) in Paris,
France.
“Each of these posters highlights our increasing knowledge of
how TXL™ and CRV431 may best be positioned for combination therapy
in the treatment of HBV,” commented Robert Foster, Chief Scientific
Officer of ContraVir. “We are particularly thankful to our partners
at the Faculty of Pharmacy & Pharmaceutical Sciences at the
University of Alberta, Baruch S. Blumberg Institute, Scripps
Research Institute and Li Ka Shing Institute of Virology whose
support has been monumental in our quest for an HBV cure.
Abstract #3094:
“Pharmacokinetic-Pharmacodynamic Modeling of Tenofovir Exalidex
(TXL™) in HBV Subjects” presented by ContraVir and the Faculty of
Pharmacy & Pharmaceutical Sciences, University of Alberta,
Canada.
Objective: To study the PK-PD relationship of
TXL™ in HBV infected patients to optimize understanding of
relationship between PK and clinical outcomes.
Results and Significance: This PK-PD study
revealed viral load reductions of TXL™ at 50 mg were comparable to
tenofovir disoproxil fumarate at 300 mg. This initial approach
using PK-PD modeling is anticipated to be used as a tool for the
future clinical development with sparse PK sampling and non-linear
mixed effects to create predictive models, as TXL™ is further
advanced in our planned registration trial.
Abstract #2615: “Assessing the in Vitro
Anti-HBV Activity of Combinations Including CRV431, TXL™ and
Prototype Core Protein Assembly Modulators” presented by ContraVir,
the Baruch S. Blumberg Institute, and the Scripps Research
Institute. ***POSTER SELECTED FOR IHEP PROGRAM
SESSIONS***
Objective: To investigate the antiviral
activity combinations of TXL™, CRV431 and prototype capsid assembly
modifiers (CpAMS) by measuring HBV DNA levels in vitro.
Results and Significance: Various combinations
of TXL™, CRV431 and CpAMs, were tested in cell lines supporting HBV
replication. As measured by the suppression of HBV DNA, synergy
scores for combinations of TXL™ with CRV431; CRV431 with CAMs; and
TXL™ with CpAMs, ranged from moderately to strongly synergistic.
None of the combinations tested showed evidence of antagonism.
Curative regimens for treatment of HBV will likely require
combination of drugs that work via different mechanisms addressing
viremia (HBV DNA), viral proteins (e.g., HBsAg, HBeAg, HBcrAg, HBx)
and the host immune response. These in vitro synergy experiments
demonstrate the potential of TXL™, CRV431, and CpAMs as useful
components of future potentially curative HBV therapies.
Abstract #2624: “HBV Peptide Array Demonstrates
Candidate Mechanisms of CRV431 Anti-HBV Activity” presented by
ContraVir and the Li Ka Shing Institute of Virology, University of
Alberta, Canada
Objective: To determine whether cyclophilin A
can bind to specific HBV peptides, and whether CRV431 blocks
binding interactions, to further the understanding of the mechanism
of action of CRV431.
Results and Significance: Multiple experiments
evaluated the binding of cyclophilin with the HBV genome, including
preS1 HBsAg, polymerase, precore, and core antigens. Cyclophilin A
bound to 10 HBV-derived peptides. All binding events were inhibited
by CRV431. Peptide binding suggests a role for CRV431 in regulation
of polymerase nuclear import, HBsAg transport and secretion, and
capsid formation. Confirmation of CRV431 and HBV protein
interactions provide important insights into how CRV431 disrupts
the HBV life cycle. Furthermore, understanding these interactions
may offer guidance on how best to utilize CRV431 in combination
therapy which, in turn, may offer further insights into a curative
anti-HBV regimen.
Detailed poster presentations can be accessed by visiting the
scientific literature section
https://contravir.com/scientific-literature/ on ContraVir’s
website.
About TXL™Tenofovir exalidex (TXL™) is a highly
potent prodrug of the antiviral tenofovir. Tenofovir is the
active component of both Vemlidy®(tenofovir alafenamide) and
Viread® (tenofovir disoproxil fumarate). TXL™’s novel
liver-targeting prodrug structure results in decreased systemic
circulating levels of tenofovir, thereby reducing the potential for
off-target effects, including renal and bone side effects.
ContraVir has completed a Phase 2 trial of TXL™, in which
HBV-infected subjects were administered doses up to 100 mg for 28
days. The oral dosage formulation is now being optimized to further
enhance drug delivery to the liver. To date, TXL™ has achieved
clinical proof of concept for antiviral activity and displayed an
excellent safety, tolerability, and pharmacokinetic profile. Based
on the agent’s best-in-class potential, ContraVir believes TXL™ can
become the cornerstone of a curative combination therapy for
hepatitis B, as HBV DNA levels were significantly reduced in
clinical trials.
About CRV431CRV431 is a non-immunosuppressive
analog of cyclosporine A (CsA) whose primary biochemical action is
inhibition of cyclophilin isomerase activity, playing a key role in
protein folding. Other viruses such as HIV-1 and HCV, similarly use
cyclophilins for their replication. CRV431 shows potential in
experimental models to complement current hepatitis B treatments by
reducing multiple markers of infection including HBV DNA, HBsAg,
HBx, HBeAg, and HBV uptake by cells. Studies have also demonstrated
that CRV431 possesses anti-fibrotic activity which may further curb
progression of liver disease in patients.
About ContraVir Pharmaceuticals ContraVir is a
biopharmaceutical company focused on the development and
commercialization of targeted antiviral therapies with a specific
focus on developing a potentially curative therapy for hepatitis B
virus (HBV). The company is developing two novel anti-HBV compounds
with complementary mechanisms of action. TXL™, designed to deliver
high intrahepatic concentrations of TFV while minimizing off-target
effects caused by high levels of circulating TFV (bone and kidney),
recently completed a Phase 2a trial. CRV431, the other anti-HBV
compound, is a next-generation cyclophilin inhibitor with a unique
structure that increases its potency and selective index against
HBV. In vitro and in vivo studies have thus far demonstrated that
CRV431 reduces HBV DNA and other viral proteins, including surface
antigen (HBsAg). For more information
visit www.contravir.com.
Forward Looking Statements Certain statements
in this press release are forward-looking within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
may be identified by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimated" and "intend,"
among others. These forward-looking statements are based on
ContraVir's current expectations and actual results could differ
materially. There are a number of factors that could cause actual
events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not
limited to, substantial competition; our ability to continue as a
going concern; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties with respect to
lengthy and expensive clinical trials, that results of earlier
studies and trials may not be predictive of future trial results;
uncertainties of government or third party payer reimbursement;
limited sales and marketing efforts and dependence upon third
parties; and risks related to failure to obtain FDA clearances or
approvals and noncompliance with FDA regulations. As with any drug
candidates under development, there are significant risks in the
development, regulatory approval, and commercialization of new
products. There are no guarantees that future clinical trials
discussed in this press release will be completed or successful, or
that any product will receive regulatory approval for any
indication or prove to be commercially successful. ContraVir does
not undertake an obligation to update or revise any forward-looking
statement. Investors should read the risk factors set forth in
ContraVir's Form 10-KT for the year ended December 30, 2017 and
other periodic reports filed with the Securities and Exchange
Commission.
For further information, please contact: Sharen
Pyatetskaya Director of Investor Relations sp@contravir.com; (732)
902-4028
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